Quality Assurance Specialist

Lupin Pharmaceuticals · Coral Hills, MD · 1 wk ago

On-siteQuality AssuranceFull-time

About the Role

Lupin is a fast-growing, innovative team with manufacturing, Research and Development, and commercial divisions focused on generic and branded U.S. business, including women’s health. This position is responsible for the lifecycle management of master documents, ensuring compliance with applicable regulations, company procedures, and industry standards. The role also involves control of controlled documents, with emphasis on document issuance, archival, and retrieval at Lupin’s Coral Springs, Florida site.

Responsibilities

Participate in the design and development of Lupin’s Quality Systems and support continuous improvement and management of these systems.
Issue GMP documents such as logbooks, notebooks, and batch records.
Liaise with subject matter experts (SMEs) and stakeholders to ensure documents are accurate, complete, and delivered within timelines.
Collaborate with functional departments to identify additional procedural controls for overall compliance improvement.
Support internal and third-party audits at the LIR site.
Partner with other functional areas (Operations, Product Development, Quality Control, Engineering and Facilities, Manufacturing, and Supply Chain) to ensure site continuous compliance.
Support the employee training program.
Manage QA retain samples and archival of GMP documents.
Provide support in the documentation of investigations and Root Cause Analysis.
Perform other QA duties as assigned.

Requirements

A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology, or a Pharmacy-related field is preferred.
A minimum of 1-3 years’ experience in an FDA-regulated environment within a Quality Assurance department, with experience in document control.
A good understanding of cGMP regulations as they apply to Drugs and Medical Devices.
Ability to enforce adherence to internal quality policies, procedures, and cGMP.
Ability to interface and work with a diverse group of departments and individuals.
Team-oriented with excellent interpersonal skills.
Ability to express regulatory requirements clearly and understandably.
Strong oral and written communication skills in English.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Work is primarily performed in an office environment.

Competencies